Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff and stakeholders entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This draft guidance, when finalized, will explain our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame (non-listed food allergen). (In April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add sesame to the definition of "major food allergen." This statutory requirement goes into effect on January 1, 2023). We are also announcing an opportunity for public comment on our proposed collection of information. This draft guidance is not final nor is it in effect at this time.